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The post-illumination pupil respOnse and its relation with Sleep quality and skin temperature in patients with a history of optic Chiasm Compression

The post-illumination pupil respOnse and its relation with Sleep quality and skin temperature in patients with a history of optic Chiasm Compression - Out-of-SynCC

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON47454
Enrollment
60
Registered
2016-07-15
Start date
2017-03-27
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

optic chiasm compression

Interventions

None listed

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: * > 18 years * At least one impaired central endocrine axis * Clearly documented cause of hypopituitarism * Adequate replacement of hormone deficiencies * Patients with history of chiasm compression: documentation of visual field defects or loss of visual acuity and a suprasellar extending tumour on MRI (before treatment)

Exclusion criteria

Exclusion criteria: * Ocular pathology that could influence the PIPR * Impaired colour vision * Previous intra-ocular surgery * Hypersensitivity to tropicamide * Use of medicinal eye drops or systemic medication that can affect the pupillary response; assessed on an individual basis * Pituitary surgery 3 time zones the month prior to examination * Pregnancy * Other comorbidity that could interfere with the study procedures; assessed on an individual basis

Design outcomes

Primary

MeasureTime frame
Difference in PIPR after a blue-light stimulus between the two groups; expressed in two parameters: - PIPR-mm = baseline pupil diameter (mm) * post-blue pupil diameter (mm) - PIPR-% = 100 x PIPR-mm/baseline pupil diameter (mm)

Secondary

MeasureTime frame
* Differences in questionnaire results on sleep quality, chronotype, fatigue and depression (MCTQ, HDSQ, PSQI, ESS, ISI, BQ, MFI-20, HADS) * Differences in polysomnography, actigraphy & sleep diary results * Differences in skin temperature results * Correlations between parameters of PIPR, sleep, sleep-wake rhythm and skin temperature

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)